510(k) K990284

BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE by Baylis Medical Co., Inc. — Product Code DXF

K990284 is an FDA 510(k) premarket notification submitted by Baylis Medical Co., Inc. for the device "BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE". The FDA issued a decision of Substantially Equivalent on February 1, 2001. The device falls under product code DXF (Catheter, Septostomy), a Class II device regulated under 21 CFR 870.5175. Baylis Medical Co., Inc. has at least 10 other 510(k) clearances on record.